Fibrin Glue Versus Titanium Platelet-rich Fibrin in Lateral Sinus Lifting

Sinus Floor Augmentation Clinical Trial

Official title:

Fibrin Glue Versus Titanium Platelet-rich Fibrin as a Sole Filling Material in Lateral Sinus Lifting With Simultaneous Implant Placement (Randomized Controlled Clinical Trial )

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05831267
• Other study ID #: Sinus_lifting_2022
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair. Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate, and regenerate bone. The aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with simultaneous implant placement in comparison to a negative control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients requiring implant placement in the posterior maxilla.
• Tooth extractions at the implant sites were performed at least 4 months before surgery.
• Residual bone height between the alveolar bone crest and the sinus floor is 3-5 mm

Exclusion Criteria:

• Maxillary sinus pathologies (sinusitis, long-standing nasal obstruction).
• Any disease-contraindicating surgery (e.g. uncontrolled diabetes).
• Heavy smokers (smoke greater than or equal 25 cigarettes daily).
• Acute oral infections.
• Untreated periodontal disease (gingival index 2 and 3).
• Poor oral hygiene ( Silness-Löe index (score 2-3) ).
• A history of radiotherapy or chemotherapy of the head and neck region.
• Pregnancy.

Related Conditions & MeSH terms

• Sinus Floor Augmentation

Intervention

Other:
• Fibrin Glue
Blood samples were collected from the antecubital vein of the right or left arm of the patient and drawn into sterile Titanium tubes immediately. The tubes were then centrifuged for 12 minutes at 2800 rpm and room temperature
• T-PRF
The contents of the two containers (human fibrinogen, human thrombin) will be mixed with distilled water and then aspirated by two syringes after that, the two solutions will be mixed together and injected into the empty compartment around the dental implant under the sinus mucosal lining using auto mixing applicator.
• Negative control
this group will not receive any material.

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in implant stability	implant stability will be measures using Ostell device.	Baseline and 6 months
Primary	change in bone density	bone density will be measured using CBCT	Baseline and 6 months
Primary	change in vertical bone height	vertical bone height will be measured using CBCT	Baseline and 6 months
Secondary	change in pain intensity	This will be assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively.; (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)	Through 1 week postopertaive
Secondary	Change in edema score	The score will be as follows: None (no inflammation); Mild (intraoral swelling confined to the surgical field); Moderate (extraoral swelling in the surgical zone); Severe (extraoral swelling spreading beyond the surgical zone)	Through 1 week postopertaive